Cleared Traditional

K924878 - NEW DETECTOR OPTION

K924878 is the FDA 510(k) clearance for NEW DETECTOR OPTION by Adac Laboratories. It is a Class 1 Radiology device (product code IYX) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K924878 · Adac Laboratories · Radiology device
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Jan 1993
Decision
136d
Days
Class 1
Risk

K924878 is an FDA 510(k) clearance for the NEW DETECTOR OPTION. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Adac Laboratories (Milpitas, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K924878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date January 15, 1993
Days to Decision 136 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 107d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 64
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K924878.
THYRUS
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NEUROCAM
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K905074 · Siemens Gammasonics, Inc. · Jun 1991